INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE

This is an interventional treatment trial for Ischemic Stroke Read More

Inclusion Criteria:

• Female or male aged≥18 years and<80years.
• Acute moderate/severe ischemic stroke, 4≤NIHSS（National Institute of Health stroke scale）≤18 at the time of randomization.
• Patients can be randomized within 72 hours of symptoms onset.
• Provision of informed consent prior to any study specific procedures. * Symptom onset is defined by the "last seen normal" principle

Exclusion Criteria:

• Diagnosis of intracerebral hemorrhage such as cerebral hemorrhage, subarachnoid hemorrhage, etc.
• Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI.
• Moderate to severe ischemic stroke induced by angioplasty/vascular surgery.
• Modified Rankin Scale Score>2 at randomization (pre-morbid historical assessment).
• History of aneurysm (including intracranial aneurysm or peripheral aneurysms).
• Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, atrial myxoma, prosthetic cardiac valves known or suspected endocarditis).
• History of Hemostatic disorder, systemic bleeding, thrombocytopenia or neutropenia.
• History of previous symptomatic non-traumatic intracerebral bleed or cerebral artery amyloidosis.
• Gastrointestinal (GI) bleed within the past 6 months before randomization.
• Major surgery within the past 3 months before randomization.
• Severe renal or hepatic insufficiency. (Severe hepatic insufficiency is defined as alanine aminotransferase (ALT) value>3 times normal upper limit or Aspartate aminotransferase (AST)>2 times normal upper limit; Severe renal insufficiency is defined as creatinine>2 times normal upper limit).
• Diagnosis or of acute coronary syndrome.
• Other antithrombotic therapy are required during the study, including antiplatelet therapy(such as open-labeled aspirin, GPIIb/IIIa inhibitors, clopidogrel, ticagrelor, prasugrel, dipyridamole, ozagrel, cilostazol, etc.) and anticoagulant therapy(such as warfarin, thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, heparin and low molecular heparin, etc.).
• Within randomized 24 hours prior to any venous or arterial thrombolysis, mechanical bolt, snake venom, defibrase, lumbrokinase, etc.
• Heparin or oral anticoagulants were used within 10 days of randomization.
• Have a history of drug or food allergy and are known to be allergic to the study drug ingredients
• Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months (if clinically indicated, vascular imaging should be performed prior to randomization whenever possible)
• Anticipated requirement for long-term (>7 days) non-steroidal antiinflammatory drugs (NSAIDs).
• The blood pressure needs to be controlled within the range of 90mmHg/60mmHg to 220mmHg/120mmHg.
• Suffering from serious cardiopulmonary disease, the researchers believe that it is not suitable for this study
• Patients with life expectancy<3 months or patients who are unable to complete the study for other reasons.
• Women of childbearing age who are negative in pregnancy test but refuse to practice reliable contraception. Women who are pregnant or lactating.
• Involving in other investigational drug or device tests within the past 30 days before randomization.
• Inability of the patient to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorders